K863450 is an FDA 510(k) clearance for the SULKY SPECIAL. This device is classified as a Stroller, Adaptive (Class I - General Controls, product code LBE).
Submitted by Asc Corp. (Troy, US). The FDA issued a Cleared decision on October 23, 1986, 50 days after receiving the submission on September 3, 1986.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3850.
| 510(k) Number | K863450 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1986 |
| Decision Date | October 23, 1986 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | LBE — Stroller, Adaptive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3850 |